- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002370
Study of Itraconazole in Patients With Advanced HIV Infection
Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14215
- Erie County Med Ctr / Pharmacy D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry.
Patients must have:
- Documented HIV infection.
- CD4 lymphocyte count < 300 cells/mm3.
- No clinically significant abnormalities, elicited by history and physical examination.
- No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry.
- Negative urine screening.
- No clinically significant abnormalities of electrocardiogram.
Prior Medication:
Allowed:
Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days.
- Unable to swallow oral solution.
- Obesity greater than 25% of ideal body weight.
Concurrent Medication:
Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
- Terfenadine.
- Astemizole.
- Cisapride.
- H2 blockers.
- Omeprazole.
- Continual antacids.
- Didanosine.
- Any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds.
Patients with the following prior symptoms and conditions are excluded:
- Previous hypersensitivity to azole antifungals.
- History of surgical procedure that may interfere with absorption of itraconazole.
- History of significant blood loss in the previous 30 days.
Prior Medication:
Excluded:
Excluded within 15 days prior to study entry:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
Excluded within 8 weeks prior to study entry:
- Change in antiretroviral therapy.
Risk Behavior:
Excluded:
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
Other Study ID Numbers
- 254B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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